(27 days)
These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
The materials of construction stainless steel, nitinol, platinum are consistent with guidewires presently in commercial distribution. The wires are available straight, or with "J" end. The wires range from .014" diameter through .065" diameter and lengths from 20cm. to 360 cm. The wires are coated with a transparent conformal coating.
The provided text is a 510(k) summary for a medical device (Galt Medical's Vascular Guidewires (Mandrel Type)). This type of submission to the FDA focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device performance in the way typically associated with AI/software medical devices.
Here's why and what information can be extracted:
- No Acceptance Criteria or Performance Study: The 510(k) summary for these guidewires operates on the principle of substantial equivalence. This means the manufacturer is asserting that their device is as safe and effective as a legally marketed predicate device, primarily based on similar technological characteristics and indications for use. They are not required to conduct a de novo clinical study to set and meet specific performance criteria (e.g., sensitivity, specificity, accuracy) akin to what would be expected for novel AI algorithms.
- Focus on Substantial Equivalence: The entire document revolves around demonstrating that "Galt Medical's Sitefinder guidewires are substantially equivalent to the currently marketed predicate devices" (K982559 and K021990). The "Conclusions" section explicitly states this.
Based on the provided text, I cannot complete the requested tables and sections because the document describes a 510(k) submission for a physical medical device (guidewires) based on substantial equivalence, not a performance study against acceptance criteria for an AI or software device.
However, I can extract the following relevant information about the device itself and the regulatory process:
Device Information from the 510(k) Summary:
- Device Name: Sitefinder Vascular Guidewire (Trade Name), Guidewire (Classification Name)
- Manufacturer: Galt Medical Corp.
- Device Description:
- Materials: Stainless steel, nitinol, platinum (consistent with currently distributed guidewires).
- Forms: Straight or with "J" end.
- Dimensions: .014" to .065" diameter, 20cm to 360 cm length.
- Coating: Transparent conformal coating.
- Intended Use/Indications for Use: "These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature." (Also mentions pacing leads in the FDA letter).
- Predicate Devices: K982559 and K021990.
- Regulatory Class: Class II
- Product Code: DQX
Why the requested information isn't present in this type of document:
This 510(k) summary is for a physical medical device, not a software or AI product. For physical devices seeking 510(k) clearance, the primary demonstration is substantial equivalence to a predicate device. This typically involves:
- Comparing indications for use.
- Comparing technological characteristics (materials, design, performance specifications, safety features).
- Bench testing to ensure the device performs as intended and is equivalent to the predicate, often against recognized standards.
- Biocompatibility testing.
It does not involve:
- Clinical studies with acceptance criteria based on diagnostic performance metrics (e.g., sensitivity, specificity for an AI).
- Human reader studies comparing AI-assisted vs. unassisted performance.
- Establishing ground truth with medical experts for an image dataset.
If this were an AI/software device, the 510(k) summary would look very different, and it would likely include information on performance metrics, study design, and ground truth establishment.
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JUL 17 2003
KC0319/6
510(k) Summary of Safety and Effectiveness for Galt Medical's Vascular Guidewires (Mandrel Type) (Prepared in accordance with 21 CFRPart 807.92) Date 6/14/02
- (1) Submitter: Galt Medical Corp. 2475 Merritt Drive Garland, TX 75041 (972) 271-5177 Contact Person: David Catlin
- (2) Device Name: Guidewire Trade Name: Sitefinder Classification Name: Wire, Guide, Catheter Classification Code: DQX
- (3) Substantial Equivalency: Galt Medical Corp. Sitefinder guidewires are substantially equivalent to guidewires from K982559 and K021990.
- (4) Device Description: The materials of construction stainless steel, nitinol, platinum are consistent with guidewires presently in commercial distribution. The wires are available straight, or with "J" end. The wires range from .014" diameter through .065" diameter and lengths from 20cm. to 360 cm. The wires are coated with a transparent conformal coating.
These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
- (5) Technological Characteristics: Galt Medical's guidewires have the same indications for use and are otherwise technically the same as the predicate devices.
- (6) Conclusions: Based on the information presented in this 510(k) premarket notification, Galt Medical's Sitefinder guidewires are considered substantially equivalent to the currently marketed predicate devices.
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Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2003
Galt Medical Corp. c/o David Catlin 2475 Merritt Dr. Garland, TX 75041
Re: K031916
Galt Medical Guidewire Regulation Number: 870.1330 Regulation Name: Guidewire Regulatory Class: Class II Product Code: DQX Dated: June 18, 2003 Received: June 20, 2003
Dear Mr. Catlin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
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Page 2 - David Catlin
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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510 (k) Number (if known): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Device Name: Sitefinder Vascular Guidewire
Indications For Use: These guidewires are intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other interventional devices within the coronary and peripheral vasculature.
. . . . . . .
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| -- | ---------------------------------------------------------------------------- |
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| -------------------------------------------------------- |
| (Division Sign-Off) |
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| Division of Cardiovascular Devices |
| 510(k) Number | K031916 |
|---|---|
| --------------- | --------- |
| Prescription Use | X | OR | Over-the Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.